Hydroxyurea
- Product NDC
- 68084-284
- 11-digit product format
- 680840284
- Labeler code
- 68084
- Product ID
- 68084-284_4c118bb8-d003-3029-e063-6394a90a7d36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyurea
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA075340
- Marketing category
- ANDA
- Marketing start
- 2008-09-17
- Substance
- HYDROXYUREA
- Active strength
- 500 mg/1
- Pharmacologic classes
- Antimetabolite [EPC], Urea [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxyurea
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYUREA | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X6Q56QN5QC |
| Rxcui | 197797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-284-01 | Hydroxyurea | 100 in 1 BOX, UNIT-DOSE | CAPSULE | 100 | | 12 |
| 68084-284-11 | Hydroxyurea | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-284 | HYDROXYUREA CAPSULE [AMERICAN HEALTH PACKAGING] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240919_c84a2241-6c05-480f-8a5b-049e08c27d73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-284-01 | 68084028401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) / 1 CAPSULE in 1 BLISTER PACK (68084-284-11) | 100 blister pack | 2008-09-17 | 0000-00-00 | No | No | Current |
| 68084-284-11 | 68084028411 | 1 in 1 BLISTER PACK | | | | | | Historical |